A phase 1, single-center, double-blind study of AM103 in healthy volunteers

Amira Pharmaceuticals (USA)0 个研究点目标入组 86 人开始时间: 2007年8月9日最近更新: 2021年11月8日

试验速览

2010 Results article in https://pubmed.ncbi.nlm.nih.gov/20182424/ (added 29/10/2021)

•1. Male or female between 18 and 65 years of age (for Multiple Dose Phase, male only)
•2. Female subjects must be postmenopausal, surgically sterile, or be prepared to use two methods of contraceptives during the study and for 14 days after the end of dosing
•3. Non-smoker
•4. Good general health as determined by medical history, and by results of physical examination, vital signs, Electrocardiogram (ECG), and clinical laboratory tests obtained within 21 days (3 weeks) prior to study drug administration
•5. Able to provide written informed consent and understand and comply with the requirements of the study

•1. Prior exposure to AM103 (no subject may participate in more than one cohort)
•2. History or presence of any significant organ system disease, including phenylketonuria, as assessed by medical history, physical examination and laboratory evaluation
•3. 12-lead ECG with any abnormality judged by the Investigator to be clinically significant or QTc interval of >450 milliseconds
•4. Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug
•5. Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant
•6. Hemoglobin <7 mmol/L
•7. Positive serum test for HIV, hepatitis C or hepatitis B virus infection
•8. History of significant allergy to any medication
•9. History of alcohol or drug abuse within the past 24 months or positive urine drug screen during screening
•10. Use of any tobacco or nicotine containing product within the previous 6 months
•11. Administration of any prescription drug within 21 days (oral contraceptives permitted) or over-the-counter drug (paracetamol and ibuprofen =1 g/day permitted) or herbal supplement within 7 days of study drug administration
•12. Administration or use of any investigational drug or device within 30 days of study drug administration
•13. Blood or plasma donation within 60 days prior to dosing

发起方

Amira Pharmaceuticals (USA)